OBJECTIVES :
Skills, Experience, Qualifications, If you have the right match for this opportunity, then make sure to apply today.
Provides strategic direction in establishing and maintaining mechanisms to monitor the health of the quality compliance activities across Clinical Pharmacovigilance Medical Quality (CPMQ) team, including mechanisms for the teams to identify systematic quality compliance risks and implementation of robust mitigation plans.
Provides direction in establishing and maintaining internal functional processes and systems to enable optimization in the execution and oversight of Clinical and Safety Quality Compliance activities.
Engage with Global Quality & R&D quality compliance teams and share insights on continuous improvement that are enterprise-wide.
Engage and provide direction to CPMQ on quality compliance activities.
Key member of the Leadership Team, contributing to the design, implementation, and advancement of the Clinical and Safety Quality Compliance strategy, model, and operations.
Leads and develops the Compliance operations team for the Clinical and Safety Quality Compliance operational activities. Promote and foster a culture of learning and continuous improvement across CPMQ.
ACCOUNTABILITIES :
Provides strategic direction in establishing and maintaining mechanisms to monitor the health of the quality compliance activities across Clinical Pharmacovigilance Medical Quality (CPMQ) team, including mechanisms for the teams to identify systematic quality compliance risks and implementation of robust mitigation plans.
Provides direction in establishing and maintaining internal functional processes and systems to enable optimization in the execution and oversight of Clinical and Safety Quality Compliance activities.
Engage with Global Quality & R&D quality compliance teams and share insights on continuous improvement that are enterprise-wide.
Engage and provide direction to CPMQ on quality compliance activities.
Leads the development, implementation, and refinement of functional quality compliance processes and systems , ensuring alignment with Global Quality and R&D Quality processes.
Provide strategic direction on escalation pathways for significant non-compliance process and system issues and / or risks.
Ensuring appropriate mitigation actions and communication across CPMQ.
Accountable for embedding and implementing new & revised Global Quality and R&D quality procedures across CPMQ.
Ensure CPMQ teams have the necessary processes and systems in place to enable operational excellence through simplified, fit-for-purpose, end-to-end functional processes and tools that meet regulatory requirements and that expectations are aligned with the global processes for safety and clinical quality.
Create mechanisms to collate, trend, and interpret quality data for actionable insights across CPMQ. Ensure the proactive monitoring of the health of the QMS and the sharing of compliance metrics for CPMQ activities e.
g. audit, inspection, QE CAPA etc.
Establish mechanisms for promoting process and system enhancements and for collating and sharing best practices e.g. Inspection, Audit learnings, Serious Breaches etc.
Ensure the compliance team provides expertise and guidance across CPMQ for GCP, PV inspections . Embed the best practices into learning opportunities across CPMQ teams.
Lead the team to be Stewards of the QMS within CPMQ (e.g. Quality Events, Serious Breach, Change Control, Risk Register, Regulatory Intelligence, Gap Assessment, Audits, Inspections, CAPA, SOP management, training assignment etc).
Lead the Clinical and Pharmacovigilance Quality council.
Key member of the Leadership Team, contributing to the design, implementation, and advancement of the Clinical and Safety Quality Compliance strategy, model, and operations.
Leads the Compliance team, ensuring optimized resourcing, robust talent development, and succession planning measures are in place to promote organizational growth / elevate capabilities.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS :
BSc in a scientific or allied health / medical field (or equivalent degree).
Minimum of 8 years of increasing responsibility and relevant experience in the global pharmaceutical industry, with at least 5 years of Quality / Compliance experience.
Advanced knowledge of clinical research and pharmacovigilance throughout R&D and commercialization, and relevant regulations including GCP / GVP.
Experience must include development and implementation of audit program, hosting / leading regulatory inspections, investigation and remediation activities on a global level, and successful management of business transformation / change management initiatives e.
g. quality system integration, outsourcing strategy etc.
Excellent communication skills to convey messages. Exceptional active listening skills to understand the needs and concerns of others, which is crucial for finding win-win solutions.
Outstanding ability to apply critical thinking and problem-solving abilities to address challenges and advocate for solutions.
Demonstrated ability to succinctly translate and effectively communicate the potential impact of significant and complex issues.
Fluency in written and spoken English, additional language skills a plus.
PHYSICAL DEMANDS :
Routine demands of an office-based environment.
TRAVEL REQUIREMENTS :
Willingness to travel to various meetings, including overnight trips. Some international travel may be required.
EEO Statement :
Takeda is proud of its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state, and local laws, and any other characteristic protected by law.
Locations : Boston, MA
Boston, MA
Worker Type : Employee
Employee
Worker Sub-Type : Regular
Regular
Time Type : Full time
Full time
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